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在儿童口服花生免疫疗法与丁酸盐辅助剂 (OPIA):一个随机的,受控的试验
Peter S Hsu1,2,3, Elizabeth H Barnes4, Michelle Barnes1
1Department of Allergy and Immunology, The Children's Hospital at Westmead, Westmead, New South Wales, Australia.
概括
在儿童中,将口服丁酸盐添加到花生口服免疫疗法 (OIT) 中,耐受性很好,但没有改善持续不响应 (SU) 率. 需要进一步的研究来探索丁酸盐.
科学领域:
- 免疫学 免疫学 免疫学
- 过敏研究 研究过敏
- 临床试验 临床试验
背景情况:
- 持续不响应 (SU) 是花生口服免疫疗法 (OIT) 的一个挑战.
- 短链脂肪酸 (SCFA) 丁酸盐可以增强调节性T细胞 (Tregs) 以提高耐受性.
- 这项研究评估了丁酸盐在添加到花生OIT时的疗效和安全性.
研究的目的:
- 评估每天口服的丁酸盐是否能改善在接受OIT的过敏儿童中对花生蛋白的持续不反应.
- 评估添加丁酸盐到花生OIT的安全性和耐受性.
主要方法:
- 一个优越性随机双盲安慰剂对照试验,涉及10-16岁的花生过敏儿童.
- 参与者接受了12个月的花生OIT与丁酸盐 (OIT+丁酸盐),安慰剂 (OIT+安慰剂) 或没有OIT (对照组).
- 主要结局是退出挑战时耐受≥1000毫克花生蛋白的比例;还分析了Treg反应和SCFA水平.
主要成果:
- 73%的OIT+酸盐组和69%的OIT+安慰剂组耐受1000毫克以上的花生蛋白;两组之间没有显著差异.
- 0%的对照组容忍了目标剂量.
- 在两组OIT中,胃肠道问题是最常见的不良事件 (73%);每组OIT中有15%发生过敏反应,AE率没有显著差异.
结论:
- 在儿童中,添加口服丁酸盐到花生OIT的耐受性很好.
- 酸盐补充剂在这个队列中没有显著提高持续不响应率.
- 这项试验为丁酸盐作为食物过敏的辅助疗法提供了宝贵的安全性和疗效数据.
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